March 31, 2015 by Steve Levine

Lawsuits Rising For Zofran Related Birth Defects

Pregnant-WomanZofran (ondansetron) was first approved to treat severe nausea in cancer patients by the U.S. Food and Drug Administration (FDA) in. This prescription medication was then prescribed to pregnant women experiencing morning sickness usually during the first trimester. It appears that with recent studies, Zofran may come with serious side effects for both mother and baby.

Side Effects of Zofran

GlaxoSmithKline (GSK) potentially saw another use for their drug and began to market Zofran for “off label” use to help treat pregnant women with severe nausea. According to the FDA, pregnant women taking Zofran can potentially lead to serious birth defects, yet Zofran is still frequently prescribed for this off-label use.

The FDA has not pulled Zofran from the shelves despite the potential risks, yet doctors must legally inform all pregnant women of the potential risks.

Side Effects of Zofran include:

  • Heart defects
  • Musculoskeletal anomalies
  • Mouth deformities
  • Jaundice

A 2011 study performed by a grant from the Centers for Disease Control and Prevention (CDC) found that Zofran doubles the risks of birth defects.

Zofran Lawsuits

Though some pregnant women have found that Zofran has eased their nausea and vomiting, others have filed birth injury lawsuits against GSK. Additionally, many women have experienced and reported adverse effects from Zofran that directly affect them.

These adverse effects to the mother may include:

  • Rashes, hives and itching
  • Shortness of breath
  • Body swelling
  • Constipation
  • Irregular heartbeat
  • Dizziness and Fainting
  • Difficulties swallowing

Ironically, GSK has faced a lawsuit before. Back in 2012, GSK had the largest healthcare settle and drug company payment in the history of the U.S. in the amount of $3 billion. This was due to GSK’s failure to report safety information and their unlawful marketing with some of its drugs, including off-label use.

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